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NDC 69842-0161-10 CVS Health Triple Antibiotic with Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

CVS Health Triple Antibiotic with Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g

CVS Health Triple Antibiotic with Pain Relief is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.

Related Packages: 69842-0161-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 69842-0161-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	69842-0161
Product ID	69842-161_5cc951e4-45bd-4c40-9d78-95f8233e7002
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CVS Health Triple Antibiotic with Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate and Pramoxine HCL
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 3.5; 10000; 10
Active Ingredient Units	[USP'U]/g; mg/g; [USP'U]/g; mg/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	CVS Health
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0161-10 (69842016110)

Pricing Information	N/A
NDC Package Code	69842-161-10
Billing NDC	69842016110
Package	24 PACKET in 1 CARTON (69842-161-10) / .9 g in 1 PACKET
Marketing Start Date	2017-04-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4c60b0a2-2f6f-4ded-9d6f-96fb1f40bbd4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine HCL 10 mg

Purpose

First aid antibiotic

Pain Relief

Uses

helps prevent infection in and temporarily relieves pain due to minor:

cuts
scrapes
burns

Warnings

For external use only

Allergy alert:

do not use if you are allergic to any of the ingredients

Do not use

in or near the eyes
on large areas of the body

Consult a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

When using this product

do not use longer than 1 week

Stop use and consult a doctor if

condition persists or gets worse
symptoms last for more than 7 days or clear up and come back within a few days
a rash or other allergic reaction develops

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

clean the affected area
apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
may be covered with a sterile bandage

Other information

Store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive ingredient

Petrolatum

Distributed by CVS Pharmacy 1-800-SHOP CVS

Principal Display Panel – Packet Label

CVS Health NDC 69842-161-10

Triple Antibiotic Ointment & Pain Relief Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate• Pramoxine HCL

First Aid Antibiotic/Pain relieving Ointment

NET WT. 0.03 oz. (0.9g)

Principal Display Panel – Carton Label

CVS Health NDC 69842-161-10

Triple Antibiotic & Pain Relief Ointment

Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate•Pramoxine HCL

First Aid Antibiotic /Pain relieving Ointment

24 packets

NET WT. 0.72 oz. (20.4g)

First Aid Treatment for Minor Cuts, Scrapes and Burns

INGREDIENTS AND APPEARANCE

CVS HEALTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF

bacitracin zinc, polymyxin b sulfate, neomycin sulfate and pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-161
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [USP'U] in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [USP'U] in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-161-10	24 in 1 CARTON	04/28/2017
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	04/28/2017

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(69842-161)

Revised: 9/2017

Document Id: 5cc951e4-45bd-4c40-9d78-95f8233e7002

Set id: 4c60b0a2-2f6f-4ded-9d6f-96fb1f40bbd4

Version: 2

Effective Time: 20170908